FDA Warning Letter to Amazon: Unapproved New Drugs Sold via Online Marketplace

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to Amazon.com, Inc. following an FDA review of product labeling/claims for drug products purchased via its website in May 2026 and distributed to U.S. consumers through the “Fulfillment by Amazon” service.

In the letter dated 17 June 2026 and published on the FDA's website on 23 June 2026, the authority states that "this review was conducted as part of FDA’s public health responsibility to protect the public from unsafe, ineffective, and poor-quality drugs."

Based on the observed claims, the FDA determined that the products “Vajraang Phimosis Mini Combo,” “Penile Heal Cream,” and “Beilloso Balanitis Relief Cream” are drugs because the labeling indicates intended use for the diagnosis, cure, mitigation, treatment, or prevention of disease and/or to affect the structure or function of the body. FDA further concluded these products are “new drugs” not generally recognized as safe and effective for their labeled uses and that no approved applications are in effect for them. FDA therefore considers them unapproved new drugs and states that introducing or delivering such products for introduction into interstate commerce violates the Federal Food, Drug, and Cosmetic Act.

The FDA further emphasizes accountability and expectations for sustained compliance: "As previously stated, you are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur." FDA requested a written response within 15 business days of receipt of the letter describing corrective actions, steps to prevent recurrence, and supporting documentation.

While the cited findings focus on labeling/claims and regulatory status, the case is a timely reminder that distribution models involving online marketplaces and outsourced fulfillment do not dilute responsibility.